Kornimate/medical-research-clean huggingface dataset:
investigation of a novel sleep surface for treatment of positional sleep apnea

Conditions: Sleep Apnea, Obstructive

Summary: body position during sleep influences the severity of obstructive sleep apnea (osa). the ahi is the number of times per hour of sleep that the airway temporarily collapses at the level of the tongue or soft palate. in a significant number of individuals with osa, the severity of the condition as measured by the apnea-hypopnea index (ahi), increases in the supine (back) position and lowers in the lateral (side) position. this is called positional osa. the primary objective of this study is to determine whether sleeping with a novel sleep surface (wave sleep surface) that is used on top of a regular bed reduces the ahi in those with positional osa.

the primary objective of this study is to determine whether sleeping with the novel device (wave sleep surface) reduces the ahi in those with supine position-related osa, also known as positional osa. a secondary aim is to determine the effects of the sleep surface on subjective and objective measures of sleep in patients with positional osa.

Eligibility criteria:
inclusion criteria: we will recruit subjects who are: * 18 years of age and above * willing and able to give informed consent * prior sleep study done based on previous clinical evaluation by the subject's treating physician in the course of usual clinical care and performed no more than 12 months prior to enrollment that meets the following: * overall ahi 5-30 events/hr * at least 20 minutes of recorded sleep in the supine and nonsupine postures * positional osa defined as \> 50% reduction in the ahi between the supine and nonsupine postures and ahi \< 5hr in the nonsupine position * central apneas \< 50% of the total number of apneas and hypopneas * patients who meet the above criteria who have been prescribed cpap therapy but are non-compliant will be enrolled in the study. cpap noncompliance will be defined as average nightly use \< 4hrs/night based on a download of the cpap machine, or self- acknowledged discontinuation of cpap use. exclusion criteria: * incapable of giving informed consent * under the age of 18 * known inability to sleep in the lateral position * active titration of medication * excessive alcohol consumption * excessive alcohol use is defined as: * more than 3 glasses of wine a day * more than 3 beers a day * more than 60 ml of hard liquor a day * room air oxyhemoglobin saturation \< 88% * use of home oxygen * compliant with osa therapy * presence of severe daytime sleepiness defined as an epworth sleepiness scale score \> 16 or a prior history of falling asleep while driving * unstable medical problem such as uncontrolled hypertension. * body mass index (bmi) \> 45 kg/m2
safety of cultured allogeneic adult umbilical cord derived mesenchymal stem cell intravenous infusion for ipf

Conditions: Idiopathic Pulmonary Fibrosis

Summary: this trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of idiopathic pulmonary fibrosis

studies have shown that stem cell treatment is safe for idiopathic pulmonary fibrosis (ipf) and can improve the prognosis of afflicted patients. patients with ipf will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. the total dose will be 100 million cells. patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy. for patients with more severe disease requiring chemotherapeutic drugs such as methotrexate, an autologous t cell vaccine will be utilized created from the patient's own t cells obtained by apheresis

Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic pulmonary fibrosis * understanding and willingness to sign a written informed consent document exclusion criteria: * active infection * active cancer * chronic multisystem organ failure * pregnancy * clinically significant abnormalities on pre-treatment laboratory evaluation * medical condition that would (based on the opinion of the investigator) compromise patient's safety. * continued drug abuse * pre-menopausal women not using contraception * previous organ transplant * hypersensitivity to sulfur

Keywords: idiopathic pulmonary fibrosis ipf stem cell treatment
ct versus ceus findings of complex cystic renal lesions

Conditions: Kidney Neoplasms; Computed Tomography; Ultrasonography; Contrast Media

Summary: retrospective comparison of complex cystic renal lesions which are found with computed tomography (ct) and were controlled with contrast enhanced ultrasound (ceus).

all subjects receive an contrast enhanced ct due to different clinical indications. when a complex cystic renal lesion is found an evaluation with ceus is performed. the ceus protocol included a native baseline examination of both kidneys. after a bolus injection of 1.5 ml sonovue (bracco, milano, italy) an examination of the affected kidneys is performed over a time period of at least three minutes. an optional dose will be given when the initial examination is not conclusive, e. g. when the arterial phase is partly missed. when both examinations are done the lesions were classified using the bosniak classification system and a comparison of both methods will be done.

Eligibility criteria:
inclusion criteria: * finding of a complex cystic renal lesion exclusion criteria: * age \< 18 y, gravity
basal analog study - comparison of lantus or levemir with nph insulin from t1dm diagnosis

Conditions: Diabetes Mellitus Type 1

Summary: hypothesis: basal insulin analogs with continuous 24-hour delivery of insulin improve glycemic control during the first year of treatment of children/adolescents with type 1 diabetes mellitus (t1dm)by preserving endogenous insulin production and a close to normal balance of the gh-igf-axis. this a randomized, open-label, parallel-group trial of 120 children, 7 - 17 years of age, newly diagnosed with t1dm. the investigators will investigate whether the use of long-acting basal insulin analogs lantus (glargine) or levemir (detemir) during the first year of treatment results in improved glycemic control (hba1c) compared with insulatard (nph insulin) when given in a meal insulin therapy regimen with rapid acting novorapid (insulin aspart). the investigators will explore possible mechanisms of action by determining remaining endogenous insulin production and changes in the gh-igf-axis. the investigators will also assess changes in body composition and evaluate quality of life in each treatment arm.


Eligibility criteria:
inclusion criteria: * diagnosis of diabetes and novel to insulin therapy * age 7 - 17 years * informed consent exclusion criteria: * moderate to severe ketoacidosis (ph\<7.2 and/or standard bicarbonate \<10 mmol/l) * suspected non-type 1 * ia2 and gad65: all-antibody negative * celiac disease or other chronic disease * hypothyroidism, if not well controlled * syndromes * previous anorexia nervosa * neuro-psychiatric disease * malignancy

Keywords: basal insulin long acting insulin analogs metabolic control hba1c c-peptide igf-i gh igfbp
evaluation of the prevalence of germs slow growth in the intervertebral disc (ivd) during spinal surgery

Conditions: Prevalence of Germs; Spinal Surgery; Anterior Disc Disease; Modic 1

Summary: low back pain is one of the most frequent reasons for consultation in rheumatology. there is a strong correlation between low back pain, and the presence of a type of modic 1 signal on mri. the anomaly modic 1 results in a hypointense signal t1-weighted images and hyperintense on t2-weighted sequences (including t2 stir and / or fat sat) and contrast enhancement of the endplates after gadolinium injection; it corresponds to a replacement of normal cancellous bone of fibrovascular tissue. the origin of this inflammatory process modic 1 into the vertebra is still unknown. infectious hypothesis was raised, including contamination by germs called "slow-growth" such as propionibacterium acnes (pa). many studies interesting bacteriological analysis of disc material found the presence of bacteria (prevalence between 0 and 54%). a recent clinical trial evaluating the efficacy of antibiotic treatment compared to placebo in low back pain with modic 1; a show effectiveness of this treatment on the different clinical parameters evaluated. however skin contamination is not formally excluded, particularly in patients previously infiltrated (including epidural). our hypothesis is that the slow-growing bacteria are not involved in modic 1 type of disc disease, and the possible presence of pa or other slow-growing bacteria in samples obtained discal posterior approach would be related to intraoperative contamination or during preoperative spinal infiltrations the main objective is to assess the prevalence of germs slow growth in the intervertebral disc in the spinal surgery by anterior disc disease in type 1 modic.


Eligibility criteria:
inclusion criteria: * major patients accepted to participate in the study and who signed an informed consent. * patients with low back pain lasting for more than 6 months, disabling, with disc disease type 1 modic eligible for a disc prosthesis or arthrodesis anterior approach. * patients underwent surgery for nerve root pain by disc herniation on mri viewable with a radio-clinical concordance with or without modic 1 disc disease in the operated disc exclusion criteria: * lumbar spine surgery history within 12 months and / or presence of osteosynthesis material. * immunocompromised patients (hiv, cancer, immunosuppressive treatment, lupus, chronic infection, ...) * patients previously treated with antibiotics exceeding 15 days during last 3 months prior enrollment for a period

Keywords: modic 1 low back pain
monkeypox, biology, outcome, transmission and epidemiology -prospective follow-up of high-risk contacts

Conditions: Mpox

Summary: with the mbote-contact study, a detailed follow-up study of high-risk contacts of mpox patients will be done. the mbote-contact study will be nested in the nih-funded palm-007 clinical trial (nct05559099) and the mbote project on mpox transmission. the study will take place in maniema province, democratic republic of congo (drc). participants will be recruited among high-risk contacts of mpox patients included in the palm-007 trial. consenting contacts will be either followed daily at the central study site or visited weekly by an outreach team in the community. they will be examined daily for signs and symptoms and asked to provide daily saliva and weekly blood samples for polymerase chain reaction (pcr) and/or serology. if participants develop mpox, they are offered treatment and enrollment in the palm-007 trial.


Eligibility criteria:
inclusion criteria: * ▪ be a high-risk contact of a laboratory-confirmed mpox case, with high-risk defined as having at least one the following types of exposure: * living in the same household as an mpox patient * having had sexual contact or intercourse with an mpox patient * sleeping in the same room as an mpox patient * sharing a meal with an mpox patient * children: having played together * last exposure to the mpox index case of less than 14 days ago * patients of any age and gender (children aged \< 10 years are excluded from venous blood sampling) * patient or culturally acceptable representative is willing and able to give informed consent for participation in the study exclusion criteria: * having previously been diagnosed with mpox in the last 3 months * inability or unwillingness to comply with the proposed follow-up schedule

Keywords: monkeypox
a feasibility study to assess the visual performance and comfort of hanita g4 multifocal soft contact lenses for presbyopia at normal daily routine use

Conditions: Presbyopia

Summary: the g4 multi multifocal contact lens is a soft contact lens intended to correct far, intermediate, and near vision for individuals with presbyopia. the lens covers the cornea and part of the sclera. the lenses can be used for daily wear for up to 1 year.

study design: a clinical performance study without a control group to compare the g4multi contact lens to other approved soft contact lenses for presbyopia study objectives: 1. to assess the multifocal vision in the various ranges of the hanita g4 multi. 2. to rate the comfort of the lenses in individuals with presbyopia study population: healthy men and women above the age of 18 diagnosed with presbyopia who have used contact lenses in the past recruitment : a total of 30 subjects completing at least 1 month of participation.

Eligibility criteria:
inclusion criteria: 1. presbyopia participants with healthy eyes who are not using any ocular medications, aged 18 years and over and who have used contact lenses in the past 2. lens powers within the range available for the test lenses 3. best spectacle-corrected visual acuity equal or greater than 20/25 (less than or equal to log mar 0.1) exclusion criteria: 1. anterior segment infection, inflammation, or abnormality 2. any active anterior segment ocular disease that would contraindicate contact lens wear 3. the use of systemic or ocular medications that would contraindicate contact lens wear 4. history of herpetic keratitis 5. history of refractive surgery or irregular cornea 6. slit lamp findings that are more serious than grade 1 7. corneal vascularization greater than 1 mm of penetration 8. pathologically dry eye; 9. participation in a contact lens or contact lens care product clinical trial within the previous 30 days
local anesthetic response in ehlers-danlos syndrome (eds) and healthy volunteers

Conditions: Ehlers-Danlos Syndrome; Anesthesia, Local

Summary: local anesthetic resistance is commonly reported by patients with eds. however, there are no objective data on the occurrence of local anesthetic resistance in eds patients and in healthy volunteers. the investigators propose to collect such objective data on the frequency of drug resistance and whether any problems with local anesthesia are due to initial ineffectiveness or due to its effects dissipating too soon.

there was a prior large online questionnaire to better understand the issues around local anesthetic resistance. by november 2018, 933 eds patients (total 1059 respondents) completed the survey, 99.2% of which had previously received local anesthetics. among these patients, 88% reported that they have "had a problem with local anesthetic injection not working adequately or properly," while only 54% of respondents without eds reported a similar problem. these data suggests that local anesthetic resistance might be more prevalent in patients with eds than in the general population. if these findings are true, then this might have significant implications for the appropriate management of these patients during minor surgery and dental procedures. this study aims to assess the frequency and related issues around local anesthetic resistance in eds patients, including whether the problem is a lack of analgesia or a timing effect (short duration of action or delayed onset of action), and whether the problem relates only to some local anesthetics or whether there is a problem with the whole class of local anesthetics. this study is completing data originally collected during a 2019 eds conference.

Eligibility criteria:
inclusion criteria: * eds patients, clinically diagnosed hypermobile eds based on 2017 criteria * eds patients with genetically proven non-hypermobile eds * healthy participants, no eds * able and willing to provide informed consent exclusion criteria: * known allergy to lidocaine * unable to provide informed consent

Keywords: ehlers-danlos syndrome local anesthesia resistance
antibiotic irrigations for intra-abdominal drains

Conditions: Abdominal Abscess

Summary: intra-abdominal abscesses are pus-filled pouches in the abdominal cavity. current standard of care includes drain placement in the abscess cavity to reach source control as well as administration of systemic antibiotics. it is common practice to flush the drain on a daily basis to ensure patency. this study aims to analyze the clinical impact of a higher local concentration of antibiotics (rather than normal saline) provided through drain irrigation with an antimicrobial agent (gentamicin and/or clindamycin) compare to normal saline.

people with an abdominal abscess who undergo drain placement will have those drains irrigated twice/day with either normal saline (placebo group) or with the above antibiotic solution for a total of 7 days or less if the drain were to be removed earlier. outcomes of interest are duration of systemic antibiotics, and wbc and temperature curve.

Eligibility criteria:
inclusion criteria: * intra-abdominal abscess drained with catheter/drain * treatment with systemic antibiotics * able to consent exclusion criteria: * abscess(es) not amendable for an image guided drain placement.
a titration study of a glucagon-like peptide-1 (glp-1) analogue in patients with type 2 diabetes treated with metformin.

Conditions: Diabetes Mellitus Type 2

Summary: this 4 arm study will evaluate the tolerability, efficacy and pharmacodynamics of different doses of a glp-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. patients will be randomized to receive either subcutaneous placebo, or subcutaneous glp-1 analogue (at a dose of 20mg, or a starting dose of 20mg escalating to either 30mg or 40mg), weekly. all patients will continue on their existing metformin treatment regimen throughout the study. the anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * male,and post-menopausal or surgically sterilized female, patients, 18-75 years of age; * type 2 diabetes mellitus, with stable metformin treatment for \>=3 months; * hba1c \>=7.0% and \<=9.5% at screening; * stable weight +/-10% for \>=3 months before screening. exclusion criteria: * type 1 diabetes mellitus; * clinically significant gastrointestinal disease; * treatment with any anti-hyperglycemic medication other than metformin monotherapy during last 3 months; * use of weight-lowering medications in the last 3 months; * uncontrolled hypertension; * previous exposure to glp-1 or glp-1 analogues.
a first-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of hm15211(efocipegtrutide)

Conditions: Obesity

Summary: single ascending dose of hm15211 in healthy obese subjects.

a first-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics after single ascending dose of hm15211 in healthy obese subjects.

Eligibility criteria:
inclusion criteria: * female subjects must be non-pregnant and non-lactating exclusion criteria: * participation in an investigational study within 30 days prior to dosing
pain thresholds under high-dose topical capsaicin

Conditions: Pain

Summary: aim of the study is to determine heat pain thresholds (hpt in °c) and cold pain thresholds (cpt in °c) during topical capsaicin 8% application, and mechanical pain thresholds (mpt in g) immediately after to find out the exact skin temperature by which capsaicin initiates the application pain (heat pain threshold, hpt in °c) but also the temperature by which capsaicin does not yet trigger a cold pain (cold pain threshold, cpt in °c). moreover the investigators want to find out the mechanical pain threshold in g from topical capsaicin and to verify a prolonged effect of capsaicin on the pain thresholds.

capsaicin is the main pungent ingredient in chili peppers. topical capsaicin 8% is used for the treatment of peripheral neuropathic pain. application of capsaicin 8% provokes distinct pain by activating the transient receptor potential vanilloid 1 (trpv1) receptor. cooling the skin results in a reliable prevention of the application pain. however, the necessary cooling temperature and if cooling itself produces application pain, is unknown. materials and methods: 10 female and 10 male healthy volunteers will be enrolled in a randomised, double blind, placebo controlled, cross-over study. the left or right forearm of each subject is going to be treated with a capsaicin 8% patch (qutenza, astellas pharma, tokyo, japan) of 9 cm² or a placebo patch (demo patch, astellas pharma, tokyo, japan) of the same size for 60 min. then the other forearm (which has not been tested before) will be treated with the remaining patch. during capsaicin and placebo exposure hpt in °c and cpt in °c are going to be obtained by the thermode of a thermal sensory analyser, tsa-ii (medoc ltd., ramat yishai, israel). temperature increase/decrease of the thermode will be stopped, as soon as the subject presses a switch because of a beginning pain sensation. immediately after exposure a pin prick test will be performed 5 times in a row by pressing a mini-spike (b. braun melsungen ag, melsungen, germany) slowly against the skin of the application areal to determine the pressure necessary to provoke a sharp pain (mechanical pain threshold in g). 2 weeks later hpt, cpt, and mpt will be determined again in the areas of capsaicin and placebo exhibition.

Eligibility criteria:
inclusion criteria: * healthy volunteers 18 ore more years old exclusion criteria: * dermatologic or neurologic injuries on both thighs, (possible) pregnancy

Keywords: heat pain threshold cold pain threshold mechanical pain threshold high dose capsaicin